Treatment for Ph-negative ALL for Adults up to 65 Years
ConditionAcute Lymphoblastic Leukemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPETHEMA Foundation
About this trial
The goal of this trial is to provide a protocol for treatment for adults with Ph-negative acute lymphoblastic leukemia (ALL) and to learn if this provides higher probability of survival than the previous one. The main question is to know if the incorporation of blinatumomab for B-cell precursor ALL, substituting some chemotherapy blocks, offers better probability of survival than the previous trial, which did not use immunotherapy. In addition, T-cell precursor ALL participants will receive different treatment approaches depending on the stage of maturation of the tumor.
Eligibility criteria
Qualifiers
De novo ALL.
Age 18-65 years.
Adequate general condition (ECOG score 0-2), or >2 if due to ALL.
Negative pregnancy test for women of childbearing age.
Disqualifiers
Age > 65 years.
ALL type L3 or with mature B phenotype (sIg+) or with the cytogenetic alterations characteristic of mature B-cell ALL (t(8;14), t(2;8), t(8;22)).
Ph-positive B-cell ALL (BCR::ABL1).
Lymphoid blast crisis of chronic myeloid leukemia.
Trial design
Treatments tested in this trial
- Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL)
- Transplantation
Treatment groups
330 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov